Using protective devices for central venous catheters in children
Exploration of Central Venous Catheter Protective Devices in the Pediatric Population: A Mixed Methods Study
This study is testing a new wearable device to see if it can help protect central venous catheters in children and how satisfied parents and nurses are with it.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 0 Years to 12 Years |
| Sex | All |
| Sponsor | University of Texas Southwestern Medical Center Academic / other |
| Locations | 1 site (Dallas, Texas) |
| Trial ID | NCT05415449 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the feasibility of a wearable protective device designed for central venous catheters (CVCs) in pediatric patients aged 0 to 12 years. The study employs a mixed methods approach, beginning with qualitative interviews to gather insights from parents and nurses regarding their satisfaction with the device. Following this, quantitative data will be collected through monthly satisfaction surveys over a three-month period. The goal is to assess both the usability of the device and the overall satisfaction of caregivers and healthcare providers.
Who should consider this trial
Good fit: Ideal candidates include children aged 0 to 12 years with central venous catheters and available caregivers who can communicate in English or Spanish.
Not a fit: Patients in critical care settings or those with Tanner stage 2 breast development may not benefit from this study due to the device's design limitations.
Why it matters
Potential benefit: If successful, this study could enhance the safety and comfort of pediatric patients with central venous catheters.
How similar studies have performed: While the specific approach of using a wearable protective device is novel, similar studies have explored protective measures for CVCs in other populations with varying degrees of success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with CVCs ages 0 to 12 years of age * May currently utilizing or historically utilized the interventional wearable protective device * Caregiver or parent available * English and Spanish speaking subjects Exclusion Criteria: * • Females with Tanner 2 breast or greater breast development. Justification: the wearable device will not fit properly to secure the CVC and may increase the risk of complications. If the patient does develop breast during the time of the study, then the patient will no longer wear the wrap and will go back to securing their device in the traditional way. Tanner 2 breast development will be evaluated in the screening process of patients. * Patients in critical care services such as neonates, trauma/ neurology intensive care unit, or cardiac intensive care unit. Justification: These patients are not mobile with their CVC and not the targeted population.
Where this trial is running
Dallas, Texas
- Children's Health — Dallas, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Maria Leal, BSN, RN, CPN — Children's Health UTSW
- Study coordinator: Maria Leal, BSN, CPN
- Email: maria.leal@childrens.com
- Phone: 2144560276
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.